Under the FDA (Food & Drug Administration) rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical produ...

In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). This followed ...

Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’...

This article by Trishna Chetry, T.M. Pramod Kumar, M.P. Venkatesh and Balamuralidhara V. from JSS College highlights the complex and critical regulatory strategies a...

The entire process from discovering and developing a potential drug candidate to its delivery into the human body requires comprehensive knowledge about the roo...

A variety of in vivo, in silico, in vitro, and ex vivo model systems are available to researchers for studying the human intestinal microbiome, its functionalities a...

Obesity is a major concern for governments worldwide. In the UK alone, it is estimated that the direct costs of obesity to the National Health Service total £6 billi...

“Sepsis is the most preventable cause of death”, and every hour it is not diagnosed will increase the probability it will kill the patient by 7%, so recognising the ...

Stem cells attract a great deal of attention due to their developmental potential and lineage-independent characteristics. Adult stem cells, otherwise known as induc...

The human heart is one of nature’s engineering marvels, considering the requirement specifications for this fist-sized hollow organ that only weighs 250–300 grams. D...